Director, Medical Safety Assessment Physician
Location: Hyderabad, Telangana, India
Company: Bristol Myers Squibb
Requisition ID: R1599165
Employment Type: Full-Time
About the Company
Bristol Myers Squibb (BMS) is a global biopharmaceutical leader committed to discovering, developing, and delivering innovative medicines for patients with serious diseases. With a strong global presence across oncology, immunology, cardiovascular, and cell therapy, BMS integrates scientific excellence with robust pharmacovigilance systems to ensure patient safety throughout the product lifecycle.
Role Overview
The Director, Medical Safety Assessment Physician is a senior leadership role within Global Pharmacovigilance and Patient Safety. The position is responsible for leading safety strategy, benefit-risk evaluation, signal detection, regulatory safety reporting, and product labeling activities for assigned compounds across development and post-marketing phases.
The role functions as the Global Safety Lead and chairs Safety Management Teams (SMTs), ensuring compliance with international regulatory requirements and maintaining the highest standards of patient safety.
Experience Required
MD or equivalent medical degree (mandatory)
Postgraduate qualification or clinical experience in Internal Medicine, Oncology, Immunology, or related specialty preferred
Minimum 3+ years of experience in Pharmacovigilance (PV) or relevant pharmaceutical/biomedical field (Medical, Clinical Research, Regulatory Affairs)
Experience across drug development lifecycle strongly preferred
Prior exposure to global regulatory submissions, benefit-risk management, and safety signal evaluation is advantageous
Key Responsibilities
Global Product Safety Leadership
Lead safety activities and benefit-risk strategies for assigned compounds
Chair Product Safety Management Teams (SMTs)
Represent Patient Safety at Health Authority (HA) and Data Monitoring Committee (DMC) meetings
Safety Surveillance and Signal Management
Evaluate and manage safety signals from clinical trials, literature, spontaneous reports, and databases
Prepare and review Safety Topic Reviews and Signal Reports
Develop and document signal evaluation strategies
Regulatory and Aggregate Safety Reporting
Oversee preparation and review of Development Safety Update Reports (DSUR)
Review Periodic Benefit-Risk Evaluation Reports (PBRER)
Contribute to Clinical Trial Applications (CTA) and Marketing Authorization Applications (MAA)
Provide safety input to Clinical Study Reports (CSR), Investigator Brochures (IB), and regulatory filings
Clinical Development Support
Provide safety input to protocols, amendments, SAPs, ICFs, and CSRs
Lead development of integrated safety summaries and risk language
Support safety strategy for regulatory and advisory meetings
Post-Marketing Safety Oversight
Lead safety evaluation for marketed products
Oversee Risk Management Plans (RMPs)
Ensure safety labeling reflects emerging data
Support regulatory responses and inspections
Cross-Functional Collaboration
Liaise with Clinical Development, Regulatory, Medical Affairs, Legal, Manufacturing, and Commercial teams
Contribute to publication strategy and scientific communications
Provide internal safety training and mentorship
Core Competencies
Deep understanding of drug development and pharmacovigilance regulations
Strong benefit-risk assessment expertise
Advanced analytical and medical judgment skills
Ability to manage multiple global projects simultaneously
Strong leadership in matrix environments
Excellent written and verbal communication skills
Work Model
The role follows BMS occupancy guidelines, which may include site-essential, hybrid (site-by-design), field-based, or remote-by-design classifications depending on business requirements.
SEO & Search Keywords
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Explore more global pharmaceutical leadership opportunities at ThePharmaDaily.com.
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